BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 7947771 · Received October 9, 2018

    Report

    Report Number
    2210968-2018-76417
    Event Type
    Injury
    Date Received
    October 9, 2018
    Report Date
    September 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ARCH GYNECOL OBSTET. 2015; 291: 855¿863. DOI: 10.1007/S00404-014-3472-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TITLE: EVALUATION OF INDICATION-SPECIFIC GENUINE STRESS URINARY INCONTINENCE PROCEDURES IN A PELVIC FLOOR CENTER. THE AIM OF THIS STUDY WAS TO ASSESS THE INDICATION-RELATED SAFETY, FEASIBILITY, AND EFFICACY OF LAPAROSCOPIC BURCH COLPOSUSPENSION (LBC), OPEN BURCH COLPOSUSPENSION (OBC), AND MIDURETERAL SLING (MUS), RETROPUBIC VAGINAL TAPE (TVT), AND TRANSOBTURATOR VAGINAL TAPE (TOT) PROCEDURES FOR SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE (SUI). THE PERI-OPERATIVE OUTCOME WAS ASSESSED IN 321 PATIENTS TREATED FOR SUI BY A SINGLE SURGEON. OF THE 143 PATIENTS (AGE: (B)(6) YEARS; BMI: 27) IN THE BURCH COLPOSUSPENSION GROUP, 120 PATIENTS UNDERWENT LBC AND 23 PATIENTS UNDERWENT OB. OF THE 178 PATIENTS (AGE: (B)(6) YEARS; BMI: 30) IN THE MID-URETERAL SLING GROUP, 129 PATIENTS UNDERWENT TVT, AND 49 PATIENTS UNDERWENT TOT BETWEEN APRIL 2001 AND DECEMBER 2007 AT A SINGLE CENTER. IN PATIENTS WHO UNDERWENT TVT, A GYNECARE TVT (ETHICON) WAS USED. IN PATIENTS WHO UNDERWENT TVT, REPORTED COMPLICATIONS INCLUDED BLADDER LESION PERFORATION (N-6), BLADDER OUTLET OBSTRUCTION (N-7), DE NOVO URGENCY (N-3), AND POST-OPERATIVE INFECTION (N-2). SHORT- AND LONG-TERM SUCCESS IS AFFECTED BY BOTH THE SURGICAL TECHNIQUE AND THE LEARNING CURVE, IN ADDITION TO THE OPERATION-SPECIFIC INDICATION. AFTER ELIMINATING THE PERFORMANCE BIAS AND BIAS CAUSED BY PROCEDURE VARIATIONS, WE FOUND HIGH SAFETY AND EFFICACY FOR LBC AS A MINIMALLY INVASIVE METHOD OF FEMALE SUI CORRECTION WITH THE POSSIBILITY OF PERFORMING CONCOMITANT PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790205 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention